Systems, devices, and methods for endoscope or laparoscopic magnetic navigation

ABSTRACT

The invention provides systems, devices, and methods for the delivery, deployment, and positioning of magnetic compression devices at a desired site so as to improve the accuracy of anastomoses creation between tissues, organs, or the like.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.18/110,467 entitled SYSTEMS, DEVICES, AND METHODS FOR ENDOSCOPE ORLAPAROSCOPIC MAGNETIC NAVIGATION filed Feb. 16, 2023 (Attorney DocketNo. 121326-11503), which is a continuation of International PatentApplication No. PCT/US2022/025343 entitled SYSTEMS, DEVICES, AND METHODSFOR ENDOSCOPE OR LAPAROSCOPIC MAGNETIC NAVIGATION filed Apr. 19, 2022(Attorney Docket No. 121326-11502), which claims the benefit of U.S.Provisional Patent Application No. 63/177,162 entitled SYSTEMS, DEVICES,AND METHODS FOR ENDOSCOPE OR LAPAROSCOPIC MAGNETIC NAVIGATION filed Apr.20, 2021 (Attorney Docket No. 121326-11501), each of which is herebyincorporated by reference herein in its entirety.

The subject matter of this patent application may be related to thesubject matter of U.S. patent application Ser. No. 17/108,840 entitledSYSTEMS, DEVICES, AND METHODS FOR FORMING ANASTOMOSES filed Dec. 1, 2020(Attorney Docket No. 121326-11101), which is a continuation-in-part of,and therefore claims priority from, International Patent Application No.PCT/US2019/035202 having an International Filing Date of Jun. 3, 2019(Attorney Docket No. 121326-11102), which claims the benefit of, andpriority to, U.S. Provisional Application Ser. No. 62/679,810, filedJun. 2, 2018, U.S. Provisional Application Ser. No. 62/798,809, filedJan. 30, 2019, and U.S. Provisional Application Ser. No. 62/809,354,filed Feb. 22, 2019, the contents of each of which are herebyincorporated by reference herein in their entireties.

FIELD OF THE INVENTION

The invention relates to deployable magnetic compression devices, and,more particularly, to systems, devices, and methods for the delivery,deployment, and positioning of magnetic compression devices at a desiredsite so as to improve the accuracy of anastomoses creation betweentissues, organs, or the like.

BACKGROUND

Bypasses of the gastroenterological (GI), cardiovascular, or urologicalsystems are typically formed by cutting holes in tissues at twolocations and joining the holes with sutures or staples. A bypass istypically placed to route fluids (e.g., blood, nutrients) betweenhealthier portions of the system, while bypassing diseases ormalfunctioning tissues. The procedure is typically invasive, andsubjects a patient to risks such as bleeding, infection, pain, andadverse reaction to anesthesia. Additionally, a bypass created withsutures or staples can be complicated by post-operative leaks andadhesions. Leaks may result in infection or sepsis, while adhesions canresult in complications such as bowel strangulation and obstruction.While traditional bypass procedures can be completed with an endoscope,laparoscope, or robot, it can be time consuming to join the holes cutinto the tissues. Furthermore, such procedures require specializedexpertise and equipment that is not available at many surgicalfacilities.

As an alternative to sutures or staples, surgeons can use mechanicalcouplings or magnets to create a compressive anastomosis betweentissues. For example, compressive couplings or paired magnets can bedelivered to tissues to be joined. Because of the strong compression,the tissue trapped between the couplings or magnets is cut off from itsblood supply. Under these conditions, the tissue becomes necrotic anddegenerates, and at the same time, new tissue grows around points ofcompression, e.g., on the edges of the coupling. With time, the couplingcan be removed, leaving a healed anastomosis between the tissues.

Nonetheless, the difficulty of placing the magnets or couplings limitsthe locations that compressive anastomosis can be used. In most cases,the magnets or couplings have to be delivered as two separateassemblies, requiring either an open surgical field or a bulky deliverydevice. For example, existing magnetic compression devices are limitedto structures small enough to be deployed with a delivery conduit e.g.,an endoscopic instrument channel or laparoscopic port. When thesesmaller structures are used, the formed anastomosis is small and suffersfrom short-term patency. Furthermore, placement of the magnets orcouplings can be imprecise, which can lead to anastomosis formation inlocations that is undesirable or inaccurate.

Thus, there still remains a clinical need for reliable devices andminimally-invasive procedures that facilitate compression anastomosisformation between tissues in the human body.

SUMMARY

Various embodiments of the invention provide improved devices andtechniques for minimally-invasive formation of anastomoses within thebody. Such devices and techniques facilitate faster and less-expensivetreatments for chronic diseases such as obesity and diabetes. Suchtechniques also reduce the time and pain associated with palliativetreatments for diseases such as cancers.

For example, in some embodiments, an apparatus for capturing andmanipulating a compression anastomosis device comprises a cap configuredto attach to a delivery device with an articulating cap facia coupled tothe distal end of the cap body. In some embodiments, the cap facia maybe moveable between a closed position and a fully opened position.Various embodiments may include one or more capture devices on the capfacia configured to capture a magnetic anastomosis device.

Various embodiments of the invention may include a cap facia that isangled substantially in relation to the delivery device. The fullyopened cap facia may be pivoted away from the angled distal end of thedelivery device. Some embodiments may include capture devices comprisingmagnets. In some embodiments, the magnets may be electromagnetsproviding a fixed magnetic field strength and/or a variable magneticfield strength for capturing, holding, and releasing a compressionanastomosis device.

In some embodiments, the capture device may be capable of grasping orretaining the magnetic anastomosis device. The capture device mayinclude one or more adhesive devices.

Various embodiments include a cap facia that may be coupled to the capbody using at least one pivot, wherein the pivot may include one or morepins and/or one or more hinge and/or one or more ball-and-socket joints.

In some embodiments, the cap may include a biasing system that biasesthe cap facia toward the closed position. The biasing system may includeone or more springs.

The closed position of the cap facia may, in some embodiments, be lessthan or equal to approximately 45° relative to a nominal plane of thedelivery device. The fully opened position may be greater than or equalto 90° relative to a nominal plane of the delivery device.

In some embodiments, the cap facia may include an extension that causesthe cap facia to move from the closed position toward the fully openedposition when pressure is applied to the extension. The cap facia may beconfigured to move from the closed position to the fully-opened positionwhen a sufficient magnetic interaction force exists between a magneticanastomosis device captured by the cap facia and an opposing magneticanastomosis device.

Various embodiments may include an actuating mechanism for remotelycontrolling the position of the cap facia relative to the cap body,wherein the actuating mechanism may comprise a spring-loaded mechanismcapable of releasing the cap facia from the closed position to the fullyopened position. Various embodiments may include an actuating mechanismfor remotely controlling the position of the cap body relative to thedelivery device.

In some embodiments, the cap body is moveable relative to the deliverydevice. The cap body may include a universal joint, hinge, and/orball-and-socket joint to be moveable relative to the delivery device,

In some embodiments, the cap may comprise at least one sensor to sensethe position of the cap body and provide feedback to a user.

The cap may be formed of a substantially clear material to permitviewing through the cap. The cap facia may have a diameter greater thanthat of the cap body. The cap body may include one or more channelsextending through the cap body.

In some embodiments, the at least one channel is adapted for passingfluid and/or air through the cap body, the at least one channel isadapted for passing an instrument through the cap body, the at least onechannel is adapted for allowing visibility through the cap body, and/orthe at least one channel is adapted for delivering suction through thecap body.

Various embodiments include at least one capture device configured toautomatically release the captured magnetic anastomosis device when thecaptured magnetic anastomosis device is properly mated with an opposingmagnetic anastomosis device, and to retain the captured magneticanastomosis device when the captured magnetic anastomosis device isinsufficiently mated with an opposing magnetic anastomosis device.

In some embodiments, the delivery device is attached to the cap. Thedelivery device in some embodiments may be an endoscope, a laparoscope,or a catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

Features and advantages of the claimed subject matter will be apparentfrom the following detailed description of embodiments consistenttherewith, which description should be considered with reference to theaccompanying drawings.

FIG. 1 is a schematic illustration of an anastomosis formation systemconsistent with the present disclosure.

FIG. 2 shows several potential anatomical targets for anastomosisformation, where arrow A is stomach to small intestine, arrow B is smallintestine to large intestine, arrow C is small intestine to smallintestine, arrow D is large intestine to large intestine, and arrow E isstomach to large intestine.

FIG. 3 shows an exemplary magnetic anastomosis device delivered throughan endoscope instrument channel such that the individual magnet segmentsself-assemble into a larger magnetic structure—in this particular case,an octagon.

FIG. 4A depicts two magnetic anastomosis devices attracting each otherthrough tissue. As shown, the devices each comprise eight magneticsegments, however alternate configurations are possible. Once the twodevices mate, the tissue that is trapped between the devices willnecrose, causing an anastomosis to form. Alternatively, the tissue boundby the devices may be perforated after the devices mate to create animmediate anastomosis.

FIG. 4B shows the two magnetic anastomosis devices coupled together bymagnetic attraction, capturing the intervening tissue. In someinstances, the endoscope can be used to cut through the circumscribedtissue.

FIG. 5A shows the needle delivering a first magnetic device into a firstportion of the hollow body at the target site.

FIG. 5B shows subsequent deployment to of a second magnetic device intoa second portion of the hollow body adjacent to the target site.

FIG. 6A shows endoscopic ultrasound guided needle delivery of a magnetassembly into the gallbladder which then couples with a second magnetassembly in the stomach or duodenum as shown in FIG. 6B.

FIG. 7 illustrates a single guide element for deploying and manipulatinga magnetic anastomosis device.

FIGS. 8A, 8B, 8C, 8D, 8E, and 8F each depict the deployment of theself-closing magnetic anastomosis device with a plurality of guideelements.

FIGS. 9, 10, 11, and 12 illustrate various methods of accessing thetarget site, specifically accessing a gallbladder via an endoscopicultrasound guided procedure.

FIG. 9 illustrates the use of monopolar energy for piercing andaccessing the gallbladder.

FIG. 10 illustrates the use of a fine aspiration needle (FNA) forpiercing and accessing the gallbladder.

FIG. 11 illustrates the use of a corkscrew-type needle for piercing andaccessing the gallbladder.

FIG. 12 illustrates the use of a guidewire passed through the bile duct.

FIG. 13 shows endoscopic ultrasound guided needle piercing of thegallbladder to access the interior of the gallbladder for subsequentdelivery of a magnet assembly therein.

FIGS. 14, 15, 16 and 17 illustrate various devices for anchoring theaccess device and/or delivery device to the target site at thegallbladder. FIG. 14 illustrates a T-bar member. FIG. 15 illustrates anitinol coil (e.g., “pig tail”). FIG. 16 illustrates a balloon member ofa catheter. FIG. 17 illustrates a malecot catheter.

FIGS. 18A, 18B, 18C, 18D, 18E, and 18F illustrate a technique ofaccessing the gallbladder and delivering a pair of magnetic anastomosisdevices for the formation of an anastomosis the gallbladder tissue andadjacent tissue.

FIG. 19 illustrates a variation of design of FIGS. 18A-18F, specificallyutilizing a balloon to deliver a single magnetic anastomosis devicewithin the gallbladder, rather than delivering the pair.

FIGS. 20A, 20B, and 20C illustrate a method of accessing thegallbladder, via endoscopic ultrasound guided access and utilizing a hotinsertion tube emitting monopolar energy, and subsequently delivering amagnetic anastomosis device within the gallbladder via the hot tube.

FIGS. 21A, 21B, 21C, 21D, and 21E illustrate a technique of accessingthe gallbladder and delivering a pair of magnetic anastomosis devicesfor the formation of an anastomosis the gallbladder tissue and adjacenttissue.

FIGS. 22A, 22B, and 22C illustrate a variation of the procedure anddevices illustrated in FIGS. 21A-21E in that the magnetic anastomosisdevice is preloaded into a distal end of the malecot catheter of thedelivery device resulting in delivery and deployment of the device upontransitioning of the malecot end into an anchored position.

FIG. 23 illustrates a malecot catheter having a distal end that expandsinto the anchored position on one side of the gallbladder tissue wall.

FIG. 24 illustrates a malecot catheter having a distal end that expandsinto the anchored position on both sides of the gallbladder tissue wall.

FIGS. 25A, 25B, 25C, 25D, 25E illustrate a technique of accessing thegallbladder and delivering a pair of magnetic anastomosis devices forthe formation of an anastomosis between the gallbladder tissue andadjacent tissue (i.e., stomach or duodenum tissue).

FIGS. 26A, 26B, 26C illustrate a variation of the procedure and devicesillustrated in FIGS. 25A-25E in that the deployment sheath includes anotch on a distal end thereof configured to engage the T-bar uponadvancement through the enterotomy, thereby pushing the T-bar to theside to allow for subsequent delivery and deployment of the magneticanastomosis device.

FIGS. 27A, 27B, and 27C illustrate another variation of the procedureand devices illustrated in FIGS. 25A-25E in that, rather than includinga deployment sheath for delivering a self-assembling magneticanastomosis device, as previously described herein, the assembly ofFIGS. 27A-27C relies on the depositing of T-bars through an accessneedle, such that a grouping of T-bars are configured to self-assembleinto an array and serve as the distal anastomosis device tocorrespondingly mate with a proximal magnetic anastomosis devicepositioned on the other side to subsequently compress tissue therebetween to form an anastomosis.

FIGS. 28A, 28B, and 28C illustrate a method of accessing thegallbladder, via endoscopic ultrasound guided access needle access,utilizing a side port deployment sheath for delivery and deployment of apair of magnetic anastomosis devices.

FIGS. 29A, 29B, and 29C illustrate a knotting member configured tosecure already deployed and positioned magnetic anastomosis devices tothe target site tissues and subsequently cut guide elements or suturescoupled thereto.

FIGS. 30A, 30B, 30C, and 30D illustrate a technique of accessing thegallbladder and delivering a pair of magnetic anastomosis devices forthe formation of an anastomosis the gallbladder tissue and adjacenttissue.

FIGS. 31A and 31B illustrate a set of magnetic segments prepackaged inan unstable polarity including a plurality of guide elements, tethers,or sutures coupling adjacent segments to one another to assist inself-assembly of the magnetic segments into a polygon deployed shape.

FIGS. 32A and 32B illustrate a method of accessing the gallbladder, viaendoscopic ultrasound guided access and utilizing an access devicehaving a conductor including a “hot” tip emitting monopolar energy, andsubsequently delivering the prepackaged magnetic segments of FIGS. 31Aand 31B into the gallbladder by way of a sheath.

FIGS. 33A, 33B, and 33C illustrate a method of accessing thegallbladder, via endoscopic ultrasound guided access and utilizing aneedle for access into the gallbladder, and subsequent delivery of acoiled stack of magnetic segments configured to serve the distalanastomosis device to correspondingly mate with a proximal magneticanastomosis device positioned on the other side to subsequently compresstissue there between to form an anastomosis.

FIGS. 34A and 34B illustrate a technique of accessing the gallbladderand delivering a pair of magnetic anastomosis devices for the formationof an anastomosis between the gallbladder tissue and adjacent tissue.

FIG. 35 illustrates a magnetic anastomosis device comprising acontinuous guide element or suture that is coupled to a plurality of themagnetic segments of the device by way of eyelets positioned on each ofthe plurality of magnetic segments.

FIG. 36 illustrates one embodiment of a suture cutting arrangementwithin a deployment sheath of the delivery device, or a secondarydevice, for cutting the sutures coupled to the magnetic anastomosisdevices.

FIGS. 37A and 37B are enlarged side views illustrating an anvil/sharparrangement and a sharp/sharp arrangement for cutting sutures.

FIG. 38 illustrates a snare device (secondary device) configured to beinserted over the guide elements or sutures coupled to the magneticanastomosis devices and configured to cut said sutures or guide elementsonce they have been deployed and positioned at a target site.

FIG. 39A illustrates a snare device comprising a resistive heatingelement for cutting guide elements.

FIGS. 39B and 39C illustrate a snare device comprising a ring memberhaving a cutting edge for cutting guide elements.

FIG. 39D illustrates a secondary device configured to provide suture orguide element cutting by way of monopolar/bipolar energy.

FIG. 40 illustrates breakaway guide elements or sutures.

FIGS. 41A and 41B illustrate a detachable suture assembly.

FIG. 42 illustrates a perspective view of another embodiment of amagnetic assembly consistent with the present disclosure.

FIG. 43A illustrates advancement of a distal tip of a delivery devicethrough respective tissue walls of adjacent organs at a target site forsubsequent formation of an anastomosis therebetween.

FIG. 43B is an enlarged view of a distal end of the delivery deviceillustrating the slot extending entirely through a side of the body ofthe delivery device.

FIG. 43C illustrates delivery of a first magnetic assembly into a firstorgan.

FIG. 43D illustrates deployment of the first magnetic assembly into thefirst organ while remaining retained within the slot of the deliverydevice.

FIG. 43E illustrates a fully deployed first magnetic assembly within thefirst organ and pulling back of the delivery device to thereby draw thefirst magnetic assembly against a wall of the first organ in preparationfor delivery and deployment of the second magnetic assembly in thesecond organ.

FIG. 43F illustrates delivery of the second magnetic assembly into thesecond organ.

FIG. 43G is an enlarged view, partly in section, of the second magneticassembly advancing to a deployed state.

FIG. 43H illustrates the first and second magnetic assemblies in fullydeployed states and coupled to one another as a result of attractivemagnetic forces therebetween.

FIG. 43I illustrates the distal end of the delivery device constructedfrom two halves and configured to split apart to allow the deliverydevice to be removed from the target site while the pair of magneticassemblies remain coupled to one another to form anastomosis at thetarget site.

FIGS. 44A, 44B, 44C, and 44D are cross-sectional views of variousprofiles of magnet segments of magnetic assemblies within a workingchannel of a standard scope.

FIG. 45 provides a listing of some exemplary working channel sizesconsidered usable/feasible to deploy a magnetic array with a cage toproduce an anastomosis.

FIG. 46 is a schematic diagram showing a laparoscopic anastomosiscapture device with ability to capture a compression anastomosis deviceand present it at an angle such as to allow for easier luminaltranslation, in accordance with one exemplary embodiment.

FIG. 47 is a schematic diagram showing a laparoscopic anastomosiscapture device configured to pivot in response to pressure, inaccordance with one exemplary embodiment.

FIG. 48 is a schematic diagram showing a laparoscopic anastomosiscapture device configured to pivot using guide lines, in accordance withone exemplary embodiment.

FIG. 49 is a schematic diagram showing a laparoscopic anastomosiscapture device including a universal joint providing additional degreesof freedom, in accordance with one exemplary embodiment.

FIG. 50 is a schematic diagram showing a cap with one or more sensorsthat are in communication with an electronic interface through whichfeedback can be provided to the user, in accordance with one exemplaryembodiment.

FIG. 51 is a schematic diagram showing conditions detected by a sensorsystem, in accordance with one exemplary embodiment.

FIG. 52 is a schematic diagram showing an alternative cap configurationin which the cap is configured (e.g., spring-loaded) to open whenextended from the shaft member opening, in accordance with one exemplaryembodiment.

FIG. 53 is a schematic diagram showing a laparoscopic magnet navigationdevice for controlling movement of a magnetic device within the GI tractor other cavity, in accordance with certain exemplary embodiments.

FIGS. 54A-54J show an exemplary flexible and manipulable delivery devicehaving an angled cap for selectively delivering, capturing, andreleasing a magnetic compression anastomosis device, in accordance withone exemplary embodiment.

For a thorough understanding of the present disclosure, reference shouldbe made to the following detailed description, including the appendedclaims, in connection with the above-described drawings. Although thepresent disclosure is described in connection with exemplaryembodiments, the disclosure is not intended to be limited to thespecific forms set forth herein. It is understood that various omissionsand substitutions of equivalents are contemplated as circumstances maysuggest or render expedient.

DETAILED DESCRIPTION

Exemplary embodiments provide improved devices and techniques forminimally-invasive formation of anastomoses within the body, e.g., thegastrointestinal tract. Such devices and techniques facilitate fasterand less-expensive treatments for chronic diseases such as obesity anddiabetes. Such techniques also reduce the time and pain associated withpalliative treatments for diseases such as stomach or colon cancer.

The system generally includes an access device configured to be providedwithin a hollow body of a patient and assist in the formation of ananastomosis at a target site (a desired anatomical location) within thehollow body for formation of an anastomosis between a first portion oftissue of the hollow body at the target site and a second portion oftissue of the hollow body. The access device is configured to provideaccess to the first and second portions of tissue of the hollow body andfurther deliver and position first and second implantable magneticanastomosis devices relative to the first and second portions of tissueor adjacent tissue for the formation of an anastomosis between tissuesat the target site. The first and second implantable magneticanastomosis devices are configured to be magnetically attracted to oneanother through a defined tissue area of the combined thickness of awall of the tissues at the target site and exert compressive forces onthe defined area to form the anastomosis.

The systems, devices, and methods described herein include, but are notlimited to, various access devices for accessing a hollow body of thepatient, such as a gallbladder, and securing positioning of the accessdevice for the subsequent placement of one of a pair of magneticanastomosis compression devices. The systems, devices, and methodsdescribed herein further include various delivery devices for deliveringat least one of the pair of magnetic anastomosis compression devices tothe target site, wherein, in some instances, a delivery deviceconsistent with the present disclosure may assist in the deployment ofat least one of the pair of magnetic anastomosis compression devices andsubsequent securing to the target site and/or coupling the pair ofmagnetic anastomosis compression devices to one another. The systems,devices, and methods described herein include various embodiments ofmagnetic anastomosis compression devices and various designs fortransitioning from a compact delivery configuration to a larger deployedconfiguration, generally by way of self-assembling design.

More specifically, exemplary embodiments provide a system including adelivery device for introducing and delivering, via a minimally-invasivetechnique, a pair of magnetic assemblies between adjacent organs tobridge walls of tissue of each organ together to thereby form a passagetherebetween (i.e., an anastomosis). The delivery device is particularlyuseful in delivering the pair of magnetic assemblies to a target sitewithin the gastrointestinal tract to thereby form anastomosis betweengastric and gallbladder walls to provide adequate drainage from thegallbladder when blockage is occurring (due to disease or otherhealth-related issues).

Delivery devices of exemplary embodiments may include an anastomosiscapture device, comprising a cap for an endoscopic or laparoscopicdelivery device. The cap is capable of magnetically engaging themagnetic anastomosis device in order to control and mate it to anotheranastomosis device, forming a pair in order to create an anastomosisbetween tissues. The capture device is articulable and able to pivotrelative to the endoscope in order to engage, control, and release theanastomosis device.

Accordingly, exemplary embodiments provide improved devices andtechniques for minimally invasive formation of anastomoses within thebody, e.g., the gastrointestinal tract. Such devices and techniquesfacilitate faster and less-expensive treatments for chronic diseasessuch as obesity and diabetes. Such techniques also reduce the time andpain associated with palliative treatments for diseases such as cancers,such as stomach or colon cancer.

FIG. 1 is a schematic illustration of an anastomosis formation system 10for providing improved placement of magnetic anastomosis devices at adesired site so as to improve the accuracy of anastomoses creationbetween tissues within a patient 12. The system 10 generally includes anaccess device 14, a delivery device 15, 100, magnetic anastomosisdevices 16, 200, and an imaging modality 18.

The access device 14 may generally include a scope, including, but notlimited to, an endoscope, laparoscope, catheter, trocar, or otherdelivery device. For most applications described herein, the accessdevice 14 is an endoscope, including a delivery needle configured todeliver the magnetic anastomosis devices 16, 200. Accordingly, thesystem 10 of the present disclosure relies on a single endoscope 14 forthe delivery of the two magnetic devices 16, 200. As will be describedin greater detail herein, a surgeon may advance the endoscope 14 withina hollow body of the patient 12 and position the endoscope 14 at thedesired anatomical location for formation of the anastomosis based on avisual depiction of the location of the target site as provided by animaging modality 18. For example, the imaging modality 18 may include adisplay in which an image, or other visual depiction, is displayed tothe surgeon illustrating a target site when performing a medical imagingprocedure, including, but not limited to, ultrasound (US), wavelengthdetection, X-ray-based imaging, illumination, computed tomography (CT),radiography, and fluoroscopy, or a combination thereof. The surgeon maythen rely on such a visual depiction when advancing the endoscope 14through the hollow body so as to position the access device 14 at aportion of tissue adjacent to the other portion of tissue at the targetsite, thereby ensuring the placement of the magnetic devices 16, 200 isaccurate.

It should be noted that the hollow body through which the access device14 may pass includes, but is not limited to, the stomach 40, gallbladder42, pancreas, duodenum 41, small intestine, large intestine, bowel,vasculature, including veins and arteries, or the like.

In some embodiments, self-assembling magnetic devices 16 are used tocreate a bypass in the gastrointestinal tract. Such bypasses can be usedfor the treatment of a cancerous obstruction, weight loss or bariatrics,or even treatment of diabetes and metabolic disease (i.e. metabolicsurgery).

FIG. 2 illustrates the variety of gastrointestinal anastomotic targetsthat may be addressed with the devices of certain exemplary embodiments,such targets include stomach to small intestine (A), stomach to largeintestine (E), small intestine to small intestine (C), small intestineto large intestine (B), and large intestine to large intestine (D).Accordingly, exemplary embodiments provide improved devices andtechniques for minimally-invasive formation of anastomoses within thebody, e.g., the gastrointestinal tract. Such devices and techniquesfacilitate faster and less-expensive treatments for chronic diseasessuch as obesity and diabetes. Such techniques also reduce the time andpain associated with palliative treatments for diseases such as stomachor colon cancer.

For example, if the hollow body through which the access device 14 maypass is a bowel of the patient, the first portion may be a distalportion of the bowel and the second portion may be a proximal portion ofthe bowel. The bowel includes any segment of the alimentary canalextending from the pyloric sphincter of the stomach to the anus. In someembodiments, an anastomosis is formed to bypass diseased, mal-formed, ordysfunctional tissues. In some embodiments, an anastomosis is formed toalter the “normal” digestive process in an effort to diminish or preventother diseases, such as diabetes, hypertension, autoimmune, ormusculoskeletal disease. It should be noted that the system may be usedfor the formation of an anastomosis between a first portion of tissue ofthe hollow body at the target site and an adjacent tissue of a secondhollow body (e.g., portal between the stomach and the gallbladder, theduodenum and the gallbladder, stomach to small intestine, smallintestine to large intestine, stomach to large intestine, etc.).

In an endoscopic procedure, the self-assembling magnetic devices 16 canbe delivered using a single endoscope 14. Deployment of a magneticdevice 16 is generally illustrated in FIG. 3 . As shown, exemplarymagnetic anastomosis devices 16 may be delivered through an endoscope 14such that individual magnet segments self-assemble into a largermagnetic structure—in this particular case, an octagon. When used withthe techniques described herein, the devices 16 allow for the deliveryof a larger magnetic structures than would otherwise be possible via asmall delivery conduit, such as in a standard endoscope, if the deviceswere deployed as a completed assembly. Larger magnet structures, inturn, allow for the creation of larger anastomoses that are more robust,and achieve greater surgical success. For example, in some cases,resulting anastomosis may have a 1:1 aspect ratio relative to the finaldimensions of the assembled magnetic devices. However, exemplaryembodiments allow for larger aspect ratios (i.e., a larger anastomosisto form relative to the dimensions of the magnetic assemblies). Inparticular, prior art systems and methods that include the use ofmagnets for creating anastomosis are generally limited based on thedimensions of the working channel of the scope or catheter used fordelivering such magnets, which, in turn, limits the resulting size ofthe anastomosis. However, the magnetic assembly design of exemplaryembodiments overcome such limitations. For example, the design of themagnetic assembly, notably the coupling of multiple magnetic segments toone another via an exoskeleton, allow for any number of segments to beincluded in a single assembly, and thus the resulting anastomosis has agreater size relative to the dimensions of the working channel of thescope. For example, in some embodiments, the resulting anastomosis mayinclude an aspect ratio in the range of 2:1 to 10:1 or greater. Suchaspect ratios are described in greater detail with regard to FIGS. 44A,44B, 44C, and 44D.

Because the magnetic devices 16 are radiopaque and echogenic, thedevices 16 can be positioned using fluoroscopy, direct visualization(trans-illumination or tissue indentation), and ultrasound, e.g.,endoscopic ultrasound. The devices 16 can also be ornamented withradiopaque paint or other markers to help identify the polarity of thedevices during placement.

The magnetic anastomosis devices 16 generally comprise magnetic segments200 that can assume a delivery conformation and a deployedconfiguration. The delivery configuration is typically linear so thatthe device can be delivered to a tissue via a laparoscopic “keyhole”incision or with delivery via a natural pathway, e.g., via theesophagus, with an endoscope 14 or similar device. Additionally, thedelivery conformation is typically somewhat flexible so that the device16 can be guided through various curves in the body. Once the device 16is delivered, the device 16 will assume a deployed configuration of thedesired shape and size by converting from the delivery configuration tothe deployed configuration automatically. The self-conversion from thedelivery configuration to the deployment configuration is directed bycoupling structures 30 that cause the magnetic segments to move in thedesired way without intervention. Exemplary self-assembling magneticanastomosis devices 16, such as self-closing, self-opening, and thelike, are described in U.S. Pat. Nos. 8,870,898, 8,870,899, 9,763,664,and 10,182,821, the contents of each of which are incorporated byreference herein in their entirety.

In general, as shown in FIG. 4A, a magnetic anastomosis procedureinvolves placing a first and a second magnetic structures 16 a, 16 badjacent to first and second portions 20, 24 of tissues 26, 22,respectively, thus causing the tissues 22 and 26 to come together. Oncethe two devices 16 a, 16 b are brought into proximity, the magneticstructures 16 a, 16 b mate and bring the tissues 22, 26 together. Withtime, an anastomosis of the size and shape of the devices 16 a, 16 bwill form and the devices will fall away from the tissue. In particular,the tissues 22, 26 circumscribed by the devices will be allowed tonecrose and degrade, providing an opening between the tissues.

Alternatively, because the mated devices 16 a and 16 b create enoughcompressive force to stop the blood flow to the tissues 22, 26 trappedbetween the devices, a surgeon may create an anastomosis by making anincision in the tissues 22, 26 circumscribed by the devices, as shown inFIG. 4B.

In yet another embodiment, as will be described in greater detailherein, and shown in FIGS. 43A-43I, a surgeon may first cut into, orpierce, the tissues 22, 26, and then deliver a magnetic device 16 a, 200a into a portion 20 of the hollow body so as to place device 16 a, 200 aaround the incision on tissue 22. The surgeon may then place device 16b, 200 b into portion 24 of the hollow body so as to deliver device 16b, 200 b around the incision on tissue 26, and then allow the devices 16a, 200 a and 16 b, 200 b to couple to one another, so that the devices16 a, 16 b (200 a, 200 b) circumscribe the incision. As before, once thedevices 16 a, 16 b (200 a, 200 b) mate, the blood flow to the incisionis quickly cut off.

While the figures and structures of the disclosure are primarilyconcerned with annular or polygonal structures, it is to be understoodthat the delivery and construction techniques described herein can beused to make a variety of deployable magnetic structures. For example,self-assembling magnets can re-assemble into a polygonal structure suchas a circle, ellipse, square, hexagon, octagon, decagon, or othergeometric structure creating a closed loop. The devices may additionallyinclude handles, suture loops, barbs, and protrusions, as needed toachieve the desired performance and to make delivery (and removal)easier. Yet still, in other embodiments, such as magnetic assembly 200of FIG. 42 , a magnetic assembly may comprise a pair of magneticsegments 202, 204 generally arranged in a linear alignment with oneanother (e.g., aligned in an end-to-end fashion) and coupled togethervia a flexible exoskeleton 206 element. Such an embodiment will bedescribed in greater detail herein.

As previously described, the self-assembling magnetic anastomosisdevices 16 can be delivered to the target site via the access device 14.For example, as shown in FIG. the access device 14 may include adelivery needle 28 (e.g., an aspiration needle) used to deliver thefirst magnetic anastomosis device 16 a into the lower small intestine(through the puncture), which is then followed by deployment to of asecond magnetic device 16 b into the upper small intestine at a locationon the tissue adjacent to the target site (shown in FIG. 5B). It shouldbe noted that the delivery can be guided with fluoroscopy or endoscopicultrasound. Following self-assembly, these small intestine magneticdevices 16 a, 16 b couple to one another (e.g., magnetically attractedto one another) through a defined tissue area of the combined thicknessof a wall of the tissues at the target site and exert compressive forceson the defined area to form the anastomosis.

FIG. 6A shows endoscopic ultrasound guided needle 14 delivery of amagnet assembly 16 a into the gallbladder 42 which then couples with asecond magnet assembly 16 b in the stomach 40 or duodenum 41 as shown inFIG. 6B. Accordingly, the described procedures may also be used withprocedures that remove or block the bypassed tissues. For example,endoscopic ultrasound (EUS) 14 can be used to facilitate guidedtransgastric or transduodenal access into the gallbladder 42 forplacement of a self-assembling magnetic anastomosis device 16. Oncegallbladder 42 access is obtained, various strategies can be employed tomaintain a patent portal between the stomach 40 and the gallbladder 42or the duodenum 41 and the gallbladder 42. In another embodiment,gallstones can be endoscopically retrieved and fluid drained. Forexample, using the described methods, an anastomosis can be createdbetween the gallbladder 42 and the stomach 40. Once the gallbladder 42is accessed in a transgastric or transduodenal fashion, the gallstonescan be removed. Furthermore, the gallbladder mucosa can be ablated usingany number of modalities, including but not limited to argon plasmacoagulation (APC), photodynamic therapy (PDT), sclerosant (e.g.ethanolamine or ethanol).

FIG. 7 illustrates a single guide element 30 for deploying andmanipulating a magnetic anastomosis device 16. For example, once theself-assembling magnetic device 16 has been delivered to a tissue, it isbeneficial to be able to manipulate the location of the device 16. Whilethe device 16 can be manipulated with conventional tools such asforceps, it is often simpler to manipulate the location of the deployeddevice 16 with a guide element 30, such as a suture or wire. As shown inFIGS. 7 and 8A-8F, a variety of attachment points can be used to providecontrol over the location and deployment of a self-assembling magneticanastomosis device 16. For example, as shown in FIG. 7 , the guideelement 30 may be coupled to a single distal segment such that, uponself-assembly, the single distal segment results in an attachment pointthat provides translational freedom of movement. It is also notable thatthe configuration shown in FIG. 7 also allows a closing force to beapplied to the distal-most segment. That is, in the event that one ormore segments should become entangled with tissue, or otherwiseprevented from self-assembling, a proximal pulling force with the guideelement 30 can help the device 16 to complete self-assembly. Onceself-assembly is completed, the device 16 can be positioned with theguide element 30 to be mated with another device (not shown) to form ananastomosis, as described above. While it is not shown in FIG. 7 , it isenvisioned that additional structures, such as a solid pusher or a guidetube can be used to deploy the device 16 in the desired location.

The guide element 30 can be fabricated from a variety of materials toachieve the desired mechanical properties and bio-compatibility. Theguide element 30 may be constructed from metal, e.g., wire, e.g.,stainless steel wire, or nickel alloy wire. The guide element may beconstructed from natural fibers, such as cotton or an animal product.The guide element 30 may be constructed from polymers, such asbiodegradable polymers, such as polymers including repeating lacticacid, lactone, or glycolic acid units, such as polylactic acid (PLA).The guide element 30 may also be constructed from high-tensile strengthpolymers, such as Tyvek™ (high density polyethylene fibers) or Kevlar™(para-aramid fibers). In an embodiment, guide element 30 is constructedfrom biodegradable suture, such as VICRYL™ (polyglactin 910) sutureavailable from Ethicon Corp., Somerville, N.J.

In some embodiments, a magnetic anastomosis device 16 may includemultiple guide elements 30. For example, as shown in FIGS. 8A, 8B, 8C,8D, 8E, and 8F, a variety of attachment points can be used to providecontrol over the location and deployment of a self-assembling magneticanastomosis device 16. As shown, four guide elements 30(1)-30(4) may becoupled to four separate segments of the device 16, respectively. Eachguide element may include a distal end coupled to a respective portionof the anastomosis device, and a proximal end that can be manipulated(i.e., increased or decreased tension) to thereby manipulate thepositioning and orientation of the anastomosis device 16 once it hasself-assembled into the predetermined shape (i.e., a polygon). Forexample, as shown, guide element 30(1) is coupled to the most distal endsegment, guide elements 30(2) and 30(3) are coupled to middle segments(segments between the most distal end segment and most proximal endsegment), and guide element 30(4) is coupled to the most proximal endsegment.

FIGS. 9-12 illustrates various methods of accessing the target site,specifically accessing a gallbladder 42 via an endoscopic ultrasound 14guided procedure. FIG. 9 illustrates the use of monopolar energy on ahot probe or guide wire 43 for piercing and accessing the gallbladder42.

FIG. 10 illustrates the use of a fine aspiration needle (FNA) 28 forpiercing and accessing the gallbladder 42.

FIG. 11 illustrates the use of a corkscrew-type needle 44 for piercingand accessing the gallbladder 42.

FIG. 12 illustrates the use of a guidewire 46 passed through the bileduct 45 and piercing into the gallbladder 42.

FIG. 13 shows endoscopic ultrasound 14 guided needle 28 piercing of thegallbladder 42 to access the interior of the gallbladder 42 forsubsequent delivery of a magnet assembly 16 therein.

FIGS. 14, 15, 16 and 17 illustrate various devices for anchoring theaccess device and/or delivery device to the target site at thegallbladder 42. FIG. 14 illustrates a T-bar member 47 connected to atether 48. FIG. 15 illustrates a nitinol coil (e.g., “pig tail”) 49.FIG. 16 illustrates a balloon member 50 of a catheter. FIG. 17illustrates a malecot catheter 51.

FIGS. 18A-18F illustrate a method of accessing the gallbladder, viaendoscopic ultrasound guided access 14 and utilizing an access deviceemitting monopolar energy 43, anchoring a delivery device via the use ofa balloon catheter 50, and subsequently delivering a pair of magneticanastomosis devices 16 a, 16 b from the delivery device sheath 52 withinthe balloon 50 while the balloon 50 is anchored within the formedenterotomy between the gallbladder 42 tissue and adjacent tissue (i.e.,stomach 40 or duodenum 41 tissue), thereby deploying the devices oneither side of the respective tissues 22, 26 (i.e., first device withinthe gallbladder and second device within stomach or duodenum) for theformation of an anastomosis there between. The magnetic assemblies 16 a,16 b are stored within the balloon 50 inside of a sheath 42 of thedelivery device. By pulling back on the sheath 52 as shown in FIG. 18C,and advancing a conductor 53, the balloon 50 and magnetic assembly 16 ais deployed into the gallbladder 42. An inflation line 54 inflates theballoon 50 allowing the magnetic devices 16 a, 16 b to self-assemble.The balloon 50 has an inner channel 55 as shown in cross section FIG.18E. The monopolar energy tip 43 is then removed from the formedenterotomy as shown in FIG. 18F.

FIG. 19 illustrates a variation of design of FIGS. 18A-18F, specificallyutilizing a balloon 50 to deliver a single magnetic anastomosis device16 a within the gallbladder 42, rather than delivering the pair.

FIGS. 20A-20C illustrate a method of accessing the gallbladder 42, viaendoscopic ultrasound guided access 14 and utilizing a hot insertiontube emitting monopolar energy 43, and subsequently delivering amagnetic anastomosis device 16 within the gallbladder 42 via the hottube 43. An EUS scope 14 is advanced through the stomach 40. A monopolarenergy tip or hot insertion tube 43, utilizing a monopolar ring 56 onthe end of the tube 43, pierces the stomach and gallbladder tissues 26,22 into the gallbladder 42 and subsequently deploys a magneticanastomosis device 16 into the gallbladder 42 (FIG. 20C).

As shown in FIG. 20B, a user need only activate monopolar energy toadvance the insertion tube 43 into the gallbladder 42.

FIGS. 21A-21E illustrate a method of accessing the gallbladder 42, viaendoscopic ultrasound 14 guided access and utilizing an access devicehaving a conductor including a “hot” tip 43 emitting monopolar energy,anchoring the delivery device via the use of a malecot catheter 51, andsubsequently utilizing the malecot catheter 51 as a conduit fordelivering a magnetic anastomosis device 16 by way of a push rod 57therethrough and into the gallbladder 42 while the malecot catheter 51is anchored within the formed enterotomy between the gallbladder tissue26 and adjacent tissue 22 (i.e., stomach or duodenum tissue). The hottip 43 pierces the stomach and gallbladder tissues 22, 26, advancing thedelivery device 14 into the gallbladder 42. A conductor 53 advances thehot tip 43 into the gallbladder 42, while a push rod 57 advances themagnet array 16. As shown in FIG. 21C, a malecot catheter 51 anchors thedevice in the gallbladder 42. The surgeon need only pull back on thepush rod 57 to open the magnet array in the proximal lumen of thestomach 40. The hot tip in then advanced into the gallbladder 42 (FIG.21D). FIG. 21E demonstrates the magnetic assembly 16 being deployedthrough a slot in the malecot catheter 51 as shown in the top figure, orthrough the end 59 as shown in the lower figure. The push rod 57 isadvanced to deploy the magnets 16. The windows of the malecot catheter51 in some embodiments may have radio opaque markers 58 in order to keepthe window oriented properly.

FIGS. 22A-22C illustrate a variation of the procedure and devicesillustrated in FIGS. 21A-21E in that the magnetic anastomosis device 16is preloaded into a distal end of the malecot catheter 51 of thedelivery device 14 resulting in delivery and deployment of the device 16upon transitioning of the malecot end 59 into an anchored position.Sutures 60 may be used to guide the magnetic anastomosis device 16 fromthe malecot catheter body 51 into the distal lumen 97. The magnet 16 ispushed out of the distal end of the malecot catheter 51 and is orientedby pulling back on the sutures 60. By pushing forward on the malecotcatheter 51, the catheter windows 61 cut the sutures 60, releasing themagnetic assembly 16.

FIG. 23 illustrates a malecot catheter 51 having a distal end thatexpands into the anchored position on one side of the gallbladder 42tissue wall 26. FIG. 24 illustrates a malecot catheter 51 having adistal end that expands into the anchored position on both sides of thegallbladder tissue wall 26. In both instances, a temporary malecot maybe placed inside of the gallbladder 42 to create a temporary conduit,which allows for drainage to occur immediately and could further allowfor insufflation of the gallbladder as well. It should be noted that,any of the embodiments that provide access from the GI tract into thegallbladder (malecot, hot tube, nitinol coil, balloon, etc.),specifically any of the devices that creates a channel through which themagnetic anastomosis device 16 will pass, can also serve as a drainagechannel. More specifically, after the access channel has been created,any fluid or material within the gallbladder could be evacuated (eitheron its own or if suction is applied) before delivery of the magneticanastomosis device 16 begins. The channel could also be used to pushfluid into the gallbladder prior to draining out the gallbladder(potentially doing the fill/drain cycle a number of times) in order to‘clean’ out the gallbladder in the event that the gallbladder has excessfluid and contents within (i.e., bile or other contents).

FIGS. 25A-25E illustrate a method of accessing the gallbladder 42, viaendoscopic ultrasound guided access needle 14 (22 or 25 gauge for easyaccess), anchoring the delivery device via the use of a T-bar assembly47 and stabilizer member 62, and subsequently delivering a magneticanastomosis device 16 therethrough, via a deployment sheath 52, and intothe gallbladder 42 while the T-bar 47 is anchored within the formedenterotomy between the gallbladder tissue 26 and adjacent tissue 22(i.e., stomach or duodenum tissue). As shown in FIG. 25A, the T-bar 47is tethered 48 to the gallbladder 42 wall. The stabilizer member 62 isthen advanced to the wall of the duodenum 41 or stomach 40 for traction,as shown in FIG. 25B. The deployment sheath 52 is then advanced into thegallbladder 42, at which point the magnetic anastomosis device 16 can bedelivered, as illustrated in FIG. 25C. FIG. 25D demonstrates the T-bar47 anchoring the delivery device 14 into the gallbladder 42 wall bypulling back on the tether 48. The surgeon advances the deploymentsheath 52 to deploy the magnetic device 16 a into the gallbladder 42.The delivery device 14 may rotate in some embodiments in order to helpalign the magnetic device 16 within the gallbladder 42. FIG. 25Eillustrates the fully formed magnetic device 16 encasing or surroundingthe T-bar 47. In some embodiments, the T-bar 47 may be magnetic toengage with the anastomosis device 16.

FIGS. 26A-26C illustrate a variation of the procedure and devicesillustrated in FIGS. 25A-25E in that the deployment sheath 52 includes anotch 63 on a distal end thereof configured to engage the T-bar 47 uponadvancement through the enterotomy, thereby pushing the T-bar 47 to theside to allow for subsequent delivery and deployment of the magneticanastomosis device 16.

FIGS. 27A-27C illustrate another variation of the procedure and devicesillustrated in FIGS. 25A-25E in that, rather than including a deploymentsheath for delivering a self-assembling magnetic anastomosis device 16,as previously described herein, the assembly of FIGS. 27A-27C relies onthe depositing of T-bars 47 through an access needle 28, such that agrouping of T-bars 47 are configured to self-assemble into an array andserve as the distal anastomosis device to correspondingly mate with aproximal magnetic anastomosis device 16 b positioned on the other sideto subsequently compress tissue there between to form an anastomosis.Each T-bar 47 is magnetic and tethered to the delivery device by sutures60. FIG. 27C illustrates the multiple magnetic T-bars 47 stored linearlywithin an access needle 28 for deployment into a lumen, and tethered tothe delivery device 14 by sutures 60.

FIGS. 28A-28C illustrate a method of accessing the gallbladder 42, viaendoscopic ultrasound guided access needle access 14, utilizing a sideport deployment sheath 63 for delivery and deployment of a pair ofmagnetic anastomosis devices 16.

FIG. 28A illustrates an EUS scope 14 accessing the stomach 40 andpiercing the stomach tissue into the gallbladder 42. A distal magnet 16a is deployed into the gallbladder 42 by advancing a deployment sheath52 into the gallbladder 42. The surgeon pulls back on the deliverydevice 14 which brings a side port 63 in the delivery device fullywithin the stomach 40. The second anastomosis device 16 b is thendeployed from the side port 106 in the sheath 52.

FIG. 28B illustrates an embodiment of the device wherein there is ametal ring 64 to guide the magnet 16 out and around the delivery device14. The magnet 16 is deployed from the side port 63 of the sheath 52.The magnet 16 is caught by the metal insert 65 of the rotating ring 64.The ring 64 rotates around the delivery device 14 in order to assistdeployment and assembly of the magnet 16. In some embodiments, the ring64 may be free spinning, or may rotate when the magnet 16 is pushed out.In some embodiments the ring 64 can be actively rotated to pull themagnet 16 out.

FIG. 28C illustrates a close-up view of the metal ring 64. The metalring 64 completely surrounds the sheath 52 of the delivery device 14 andguides the magnet 16 around the delivery device 14 to assist deploymentand assembly.

FIGS. 29A-29C illustrate a knotting member 66 configured to securealready deployed and positioned magnetic anastomosis devices 16 to thetarget site tissues and subsequently cut guide elements or sutures 60coupled thereto. As shown in FIG. 29A, the knotting member 66 isadvanced over guide elements or sutures 60 within a working channel of ascope 14. The knotting member 66 is advanced through the stomach 40 byway of the scope 14 in order to cut the sutures 60 of previouslypositioned anastomosis devices 16 within the stomach 40 and gallbladder42.

As shown in FIG. 29B, the knotting member 66 advances towards themagnetic anastomosis devices 16, wherein the knotting member 66generally consists of an outer tube member 67 and an inner rod member68, such that, upon reaching the devices, the inner rod member 68 can bepressed towards a distal end of the outer tube member 67, therebysecuring a portion of the guide elements 60 there between and furthercutting the guide elements 60 in the process.

FIG. 29C illustrates the inner rod member 68 cinched against the outertube member 67 of the knotting member 66 in order to cut the sutures orguide elements 60 from the magnetic anastomosis devices 16.

FIGS. 30A-30D illustrate a method of accessing the gallbladder 42, viaendoscopic ultrasound guided access needle access 14, and delivering amagnetic coil 69 or ring configured to transition from a substantiallylinear shape to a substantially annular shape upon delivery into thegallbladder 42 and is configured to serve the distal anastomosis deviceto correspondingly mate with a proximal magnetic anastomosis device 16 bpositioned on the other side to subsequently compress tissue therebetween to form an anastomosis.

FIG. 30A illustrates an EUS scope advancing into the stomach 40. Anaccess needle 28 pierces the stomach 40 and gallbladder 42 tissue,thereby deploying a metallic coil 69 into the gallbladder 42. Themetallic coil 69 is stored in the delivery device 14 in a linear shapeas shown in FIG. 30B, and upon deployment forms a substantially annularshape. The metallic coil 69 in some embodiments is made of a laser cuthypotube to allow it to flex.

FIG. 30C illustrates the hypotube 69 advancing along a nitinol coil 49as it is deployed from the delivery device 14 into the gallbladder 42.As the metal hypotube 69 is advanced along the nitinol coil 49, itchanges form from a substantially linear shape from storage to asubstantially annular shape as it is deployed.

FIG. 30D illustrates the proximal magnet 16 b engaging with a metalhypotube 69 in order to compress the tissues therebetween and form ananastomosis.

FIGS. 31A and 31B illustrate a set of magnetic segments 202 prepackagedin an unstable polarity including a plurality of guide elements 30,tethers 48, or sutures 60 coupling adjacent segments 202 to one anotherto assist in self-assembly of the magnetic segments into a polygondeployed shape. The magnetic segments 202 are pre-packaged in anunstable polarity so that upon deployment they self-assemble into thedesired shape. End to end tethers 48 help snap the magnetic segments 202into the desired shape.

FIGS. 32A and 32B illustrate a method of accessing the gallbladder 42,via endoscopic ultrasound guided access 14 and utilizing an accessdevice having a conductor including a “hot” tip emitting monopolarenergy 43, and subsequently delivering the prepackaged magnetic segments202 of FIGS. 31A-31B into the gallbladder 42 by way of a sheath 52.

FIG. 32A illustrates an EUS scope 14 accessing the stomach 40. A “hot”tip emitting monopolar energy 43 is used to pierce the stomach 40 andgallbladder 42 tissues in order to access the gallbladder 42. Uponaccessing the gallbladder 42 a magnetic assembly 16 is deployed asillustrated in FIG. 32B.

FIG. 32B illustrates the deployment of a magnetic anastomosis device 16a into the gallbladder 42. A “hot” access tip 43 pierces the stomach 40and gallbladder 42 tissues in order to access the gallbladder 42. Asheath 52 is advanced into the gallbladder 42, in which a distalmagnetic assembly 16 a, a spacer 70, and proximal magnetic assembly 16 bare stored in a linear arrangement. By pulling back on the sheath 52,the distal magnetic assembly 16 a is deployed into the gallbladder 42,wherein it self-assembles into a polygonal shape, in this illustrationan octagon.

FIGS. 33A-33C illustrate a method of accessing the gallbladder 42, viaendoscopic ultrasound guided access 14 and utilizing a needle 28 foraccess into the gallbladder 42, and subsequent delivery of a coiledstack of magnetic segments 202 configured to serve the distalanastomosis device 16 a to correspondingly mate with a proximal magneticanastomosis device 16 b positioned on the other side to subsequentlycompress tissue there between to form an anastomosis.

As shown in FIG. 33A, the nitinol coil 49 is advanced into thegallbladder 42 by way of an access needle 28 within an EUS scope 14. Themagnetic segments 202 are then advanced around the extended nitinol coil49 held in place by a suture 60, as shown in FIG. 33B. Upon pulling asuture 60, as shown in FIG. 33C, the magnetic segments 202 collapse uponone another (due to magnetic attraction forces) and form a coiled stackof magnets 16 upon removal of the nitinol coil 49.

FIGS. 34A-34B illustrate a method of accessing the gallbladder 42, viaendoscopic ultrasound guided access 14 and utilizing a needle 28 foraccess into the gallbladder 42, and subsequent delivery of a magneticfluid or suspension of magnetic particles 71 into the gallbladder 42configured to serve as the distal anastomosis device to correspondinglymate with a proximal magnetic anastomosis device 16 b positioned on theother side to subsequently compress tissue 26, 22 there between to forman anastomosis.

FIG. 34A illustrates an EUS scope 14 accessing the stomach 40. An accessneedle 28 pierces the stomach 40 and gallbladder 42 tissues to accessthe gallbladder 42. The access needle 28 then deploys magnetic fluid orparticles 71 into the gallbladder 42.

FIG. 34B illustrates the magnetic particles 71 being attracted to adeployed proximal magnetic anastomosis device 16 b. The magneticparticles 71 form a polygonal annular shape consistent with that of theproximal anastomosis device 16 b, thereby compressing the tissue 26, 22between the devices and forming an anastomosis.

FIG. 35 illustrates a magnetic anastomosis device 16 comprising acontinuous guide element or suture 60 that is coupled to a plurality ofthe magnetic segments 202 of the device by way of eyelets 72 positionedon each of the plurality of magnetic segments 202. Eyelets 72 are placedon the inside of the magnet 16 to prevent sutures 60 from gettingtrapped or pinched between magnets 16. A continuous suture 60 is runthrough the eyelets 72 in order to guide and position the magnet 16 forformation of an anastomosis. Suture legs 73 a, 73 b, 73 c may be pulledindividually or simultaneously in order to manipulate the magnet 16. Toremove the suture 60, leg 73 a or 73 c may be pulled individually.

FIG. 36 illustrates one embodiment of a suture cutting arrangementwithin a deployment sheath 52 of the delivery device, or a secondarydevice, for cutting the sutures 60 coupled to the magnetic anastomosisdevices. A push/pull guillotine utilizing an anvil/sharp or sharp/sharpconfiguration is used to cut the sutures 60. By pushing and pulling onthe cutting arrangement, a knife edge is exposed. Pushing/pulling on thecutting arrangement also introduces tension to the sutures. The tensedsutures are pulled over the sharp edge of the cutting arrangement to becut and subsequently removed from the cutting arrangement. In someembodiments, the cutting arrangement may be twisted to expose a knifeedge to cut the sutures.

FIGS. 37A and 37B are enlarged side views illustrating an anvil/sharparrangement and a sharp/sharp arrangement for cutting sutures. FIG. 38illustrates a snare device (secondary device) configured to be insertedover the guide elements or sutures coupled to the magnetic anastomosisdevices and configured to cut said sutures or guide elements once theyhave been deployed and positioned at a target site.

FIG. 37A illustrates a sharp 74/anvil 75 cutting arrangement. A tensedsuture 60 is brought over the exposed sharp edge 74 to be cut by pushingand pulling on the cutting arrangement.

FIG. 37B illustrates a sharp/sharp cutting arrangement. By pushing andpulling on the cutting arrangement, two sharp edges 74 are exposed,cutting a tensed suture 60.

FIG. 38 illustrates a snare device 76 to cut sutures 60. A snare device76 is advanced into the stomach 40 through an endoscope or similardelivery device 14. After the magnets 16 are positioned in the desiredlocation to form an anastomosis, the snare device 76 is advanced overthe sutures 60 through a working channel of the scope 14. The snaredevice 76 cuts the sutures 60, detaching them from the deployed magneticanastomosis devices 16.

FIG. 39A illustrates a snare device 76 comprising a resistive heatingelement 77 for cutting guide elements 60. The snare member 76 comprisesa support tube 78 that guides the snare device 76 into position to cutthe sutures 60. The resistive heating element 77 may be powered by lowvoltage from a battery or a generator. By pulling on the snare device76, the resistive heating element 77 applies energy to and cuts thesutures 60, releasing them from the magnetic anastomosis device forsubsequent removal.

FIG. 39B illustrates a close-up view of the snare device 76. The snaredevice 76 may be positioned on the outside of a scope 14 or incorporatedinto a cap on the scope 14. The snare device 76 is contained within asnare sleeve 79. A deployment means or delivery needle 28 deploys themagnet 16 into the stomach 40. The snare device 76 is advanced in thesnare sleeve 79 as shown in FIG. 39C.

FIG. 39C illustrates a snare device 76 comprising a ring member 80having a cutting edge for cutting guide elements 60. The snare device 76captures the sutures 60 within the loop. By pulling back on the snaresleeve 79, the ring member 80 cuts the sutures 60, detaching them fromthe magnets 16 for subsequent removal.

FIG. 39D illustrates a secondary device configured to provide suture 60or guide element 30 cutting by way of monopolar/bipolar energy. Once themagnets 16 are in place on the tissues 22, 26, a monopolar/bipolar “hot”tip 43 is utilized to cut the sutures 60. The monopolar or bipolar tip43 is activated upon pulling back on the delivery device 14.

FIG. 40 illustrates breakaway guide elements or sutures 60. The sutures60 comprise a necked down or weakened portion 81. Upon pulling back onthe sutures 60, the sutures 60 break away at the weakened point 81,detaching from the magnetic assembly 16 for subsequent removal of thesutures 60.

FIGS. 41A and 41B illustrate a detachable suture 60 assembly. Within thesheath 52 of the delivery device 14, sutures comprising overmoldeddrivers 82 are stored in a staggered position as shown in FIG. 41A. Insome embodiments, the sutures 60 comprising overmolded drivers 82 may bestored in individual lumens. The overmolded drivers 82 are stored in aconstrained position within the sheath 52. Upon deployment by removingthe sheath 52, the overmolded drivers are no longer constrained, anddetach from one another, as shown in FIG. 41B. Upon the overmoldeddrivers 82 detaching, the sutures 60 may be removed from the patient.

Accordingly, exemplary embodiments provide improved devices andtechniques for minimally invasive formation of anastomoses within thebody, e.g., the gastrointestinal tract. Such devices and techniquesfacilitate faster and less-expensive treatments for chronic diseasessuch as obesity and diabetes. Such techniques also reduce the time andpain associated with palliative treatments for diseases such as cancers,such as stomach or colon cancer. More specifically, exemplaryembodiments provide various systems, devices, and methods for thedelivery, deployment, and positioning of magnetic compression devices ata desired site so as to improve the accuracy of anastomoses creationbetween tissues, organs, or the like.

FIG. 42 illustrates a perspective view of another embodiment of amagnetic assembly 200 consistent with the present disclosure. Themagnetic assembly 200 comprises a pair of magnetic segments 202, 204generally arranged in a linear alignment with one another (e.g., alignedin an end-to-end fashion) and coupled together via a flexibleexoskeleton element 206. The segments 202, 204 are spaced apart via acentral portion 108 of the exoskeleton 206. The central portion 208 mayinclude a connection member for receiving a corresponding connectionmember of a placement device to assist in delivery of the magneticassembly 200, as will be described in greater detail herein. Theexoskeleton may be made from a resilient material that will retain itsshape after deformation, such as a polymer or metal alloy. In someembodiments, the metal alloy will comprise nickel, such as nitinol.Exemplary exoskeleton embodiments are described in U.S. Pat. Nos.8,870,898, 8,870,899, 9,763,664, the contents of each of which areincorporated by reference herein in their entirety.

The magnetic assembly 200 is configured to be delivered and deployed ata target site via a delivery device 100. As previously described,exemplary embodiments provide improved devices and techniques forminimally-invasive formation of anastomoses within the body, e.g., thegastrointestinal tract. Such devices and techniques facilitate fasterand less-expensive treatments for chronic diseases such as obesity anddiabetes. Such techniques also reduce the time and pain associated withpalliative treatments for diseases such as cancers, such as stomach orcolon cancer. More specifically, exemplary embodiments provide a systemincluding a delivery device 100 for introducing and delivering, via aminimally-invasive technique, a pair of magnetic assemblies 16 a, 16 bbetween adjacent organs to bridge walls of tissue 22, 26 of each organtogether to thereby form a passage therebetween (i.e., an anastomosis).The delivery device 100 is particularly useful in delivering the pair ofmagnetic assemblies 16 to a target site within the gastrointestinaltract to thereby form anastomosis between gastric and gallbladder wallsto provide adequate drainage from the gallbladder when blockage isoccurring (due to disease or other health-related issues).

FIGS. 43A-43I illustrate various steps in deploying a pair of magneticassemblies 200 a, 200 b to a target site for subsequent formation ofanastomosis. In the embodiments described herein, the system generallyincludes a single scope, such as an endoscope 14, laparoscope, catheter,trocar, or other access device, through which a delivery device isadvanced to a target site for delivering and positioning a pair ofmagnetic assemblies 200 a, 200 b for subsequent formation of anastomosisat the target site. In particular, the delivery device 100 comprises anelongate hollow body 102, such as a catheter, shaped and/or sized to fitwithin the scope. The delivery device includes a working channel inwhich a pair of magnetic assemblies 200 a, 200 b is loaded. The deliverydevice further includes a distal end 104 configured to pierce, orotherwise penetrate, through tissue.

For example, FIG. 43A illustrates advancement of a distal tip of adelivery device 100 through respective tissue walls of adjacent organsat a target site for subsequent formation of an anastomosistherebetween. For example, the distal end 104 may have a sharp tip forpiercing tissue and/or may utilize energy to penetrate through tissue(i.e., a hot tip). The body 102 of the delivery device 100 furtherincludes a slot or opening 106 adjacent to the distal end 104, as shownin FIG. 43B. As shown, the slot extends entirely through a side of thebody 102 of the delivery device 100. The slot 106 is shaped and/or sizedto receive the magnetic assemblies 200 a, 200 b therethrough, such thatthe magnetic assemblies 200 a, 200 b pass through the working channeland exit the delivery device 100 via the slot 106. The delivery device100 further includes a placement member 108, generally in the form of awire or the like, that is releasably coupled to one or both of themagnetic assemblies 200 a, 200 b and provides a means of deploying themagnetic assemblies 200 a, 200 b from the distal end of the deliverydevice 100 via the slot 106.

During a procedure, a surgeon or other trained medical professional mayadvance a scope 14 (e.g., endoscope) within a hollow body of the patientand position the scope 14 at a desired anatomical location for formationof the anastomosis based on a visual depiction of the location of thetarget site as provided by an imaging modality 18 providing a medicalimaging procedure (e.g., ultrasound (US), wavelength detection,X-ray-based imaging, illumination, computed tomography (CT),radiography, and fluoroscopy, or a combination thereof). The surgeon mayadvance the distal tip 104 of the delivery device 100 through adjacentwalls of a pair of organs (i.e., through a wall of the duodenum 41 and awall of the common bile duct 45), in any manner previously describedherein. Upon advancing distal end 104, including the slot 106, into thefirst organ 45 (i.e., common bile duct), the surgeon may utilize theplacement member 108 to manually deliver and deploy a first magneticassembly 200 a into the first organ 45 via the slot. For example, FIG.43C illustrates delivery of a first magnetic assembly 200 a into thecommon bile duct 45. As shown, the placement member 108 include aconnection member 110, at attachment point 113, at a distal end of theplacement member 108, which is configured to be releasably coupled to acorresponding connection member of the central portion 208 of theexoskeleton 206 (indicated by attachment point arrow). Upon advancingand extending the placement member 108 towards the distal end 104 of thedelivery device 100, the first magnetic assembly passes from the workingchannel of the delivery device 100 and through the slot 106 totransition into a deployed state, as illustrated in FIG. 43D. As shown,deployment of the first magnetic assembly 200 a results in the pair ofmagnetic segments 202, 204 to exit the slot 106 on opposite respectivesides of the body 102 of the delivery device 100 while the centralportion 208 of the exoskeleton 206 remains within the slot 106. In otherwords, the slot 106 extends entirely through the body 102 of thedelivery device 100, from one side to the other. Accordingly, when in adeployed state, the first magnetic assembly 200 a is positioned into thefirst organ while remaining retained within the slot 106 of the deliverydevice 100.

At this point, the surgeon need only pull back upon the delivery device100 until the first magnetic assembly 200 a engages the tissue of thefirst organ and the majority of the slot 106 is positioned within thesecond organ 41. The surgeon is able to then deliver and deploy thesecond magnetic assembly 200 b into the second organ (i.e., the duodenum41). FIG. 43E illustrates a fully deployed first magnetic assembly 200 awithin the first organ and pulling back of the delivery device 100 tothereby draw the first magnetic assembly 200 a against a wall of thecommon bile duct in preparation for delivery and deployment of thesecond magnetic assembly 200 b in the duodenum.

The second magnetic assembly 200 b deploys in a similar fashion as thefirst magnetic assembly 200 a, in that magnetic segments 202, 204 of thesecond magnetic assembly 200 b exit the slot 106 on opposite respectivesides of the body 102 of the delivery device 100 while a central portion208 of an exoskeleton 206 remains retained within the slot 106. FIG. 43Fillustrates delivery of the second magnetic assembly 200 b into theduodenum. FIG. 43G is an enlarged view, partly in section, of the secondmagnetic assembly 200 b advancing to a deployed state. As shown, as thesecond magnetic assembly 200 b is advanced through the working channeland towards the slot 106, the assembly 200 b is configured to engage aramped section 112 of the placement member which assisted in directingat least one of the segments of the assembly 200 b into place, as shown.FIG. 43H illustrates the first and second magnetic assemblies 200 a, 200b in fully deployed states. The first and second magnetic assemblies 200a, 200 b are substantially aligned with one another and, due toattractive magnetic forces, the first and second magnetic assemblies 200a, 200 b will couple to one another.

As shown in FIG. 43I, the distal end 104 of the delivery device 100 iscomprised of two halves that, when in a default state, form a relativelyuniform tip shape. However, the distal end comprises a deformablematerial (i.e., shape memory material), such that, upon application ofsufficient force, the two halves will split apart. As such, once boththe first and second magnetic assemblies 200 a, 200 b have beendelivered and are effectively coupled to one another (but are stillretained within the slot 106), the surgeon need only pull back on thedelivery device 100 which then causes the magnetic assemblies 200 a, 200b to make contact with the distal end 104 and force the two halves ofthe distal end 104 to split apart, allowing the distal end of thedelivery device to be withdrawn from the target site while the pair ofmagnetic assemblies 200 a, 200 b remain in place. The pair of magneticassemblies 200 a, 200 b compress the walls 22, 26 of each respectiveorgan therebetween, subsequently forming an anastomosis between theorgans (i.e., anastomosis between the duodenum and the common bileduct).

Upon deployment, each magnetic assembly has a width and a lengthgenerally corresponding to a width of a respective segment and a lengththat is approximately twice the length of each segment. As a result, thepair of magnetic assemblies, when coupled to one another, generally forma substantially linear package and the resulting anastomosis formed maygenerally be rectangular in shape, but may naturally form a round oroval shape. The resulting anastomosis may have a 1:1 aspect ratiorelative to the dimensions of the magnetic assemblies. However,exemplary embodiments allow for larger aspect ratios (i.e., a largeranastomosis to form relative to the dimensions of the magneticassemblies). In particular, prior art systems and methods that includethe use of magnets for creating anastomosis are generally limited basedon the dimensions of the working channel of the scope or catheter usedfor delivering such magnets, which, in turn, limits the resulting sizeof the anastomosis. The magnetic assembly design overcomes suchlimitations.

For example, the design of the magnetic assembly, notably the couplingof multiple magnetic segments 202 to one another via an exoskeleton 206,allow for any number of segments 202 to be included in a single assembly16, and thus the resulting anastomosis has a greater size relative tothe dimensions of the working channel of the scope 14. For example, insome embodiments, the resulting anastomosis may include an aspect ratioin the range of 2:1 to 10:1 or greater.

FIGS. 44A-44D are cross-sectional views of various profiles of magnetsegments of magnetic assemblies within a working channel of a standardscope. The cross-sectional areas of magnets are illustrated, showingpolygons as well as ellipses and circles taking between 10 and 95percent of the annular space of the working channel. With the guidelines for the magnetic profile being in place, the next constraint forthe device is the axial ratio of a minimum of 6:1 and a maximum of 50:1.This segmented length once assembled in the body can have either aregular or irregular shape.

FIG. 45 provides a listing of some exemplary working channel sizesconsidered usable/feasible to deploy a magnetic array with a cage toproduce an anastomosis. These sizes do not limit future capabilities asscope channel sizes increase/decrease with market and device changes.The summary of sizing can be summarized into: 1.0 mm-6.0 mm (including ableed scope called the “clot buster”) with one particular sized devicedesigned around the 3.7 mm.

Accordingly, the delivery device of the present disclosure produces alow-profile linear anastomosis that would allow certain complications,particularly those associated with blockage of the common bile duct, tobe mitigated. In particular, patients experiencing a blockage of thecommon bile duct often undergo some sort of procedure to either removethe blockage or allow drainage to provide relief of jaundice/infectionand hepatic portal complications. A common procedure is asphincterotomy, or some sort of draining stent placement procedure.There are procedures which present decompression of the bile duct in atraditional way, but are not possible in a minimally noninvasive manner.Such procedures include, for example, a sphincterotomy, which is notpossible due to inability to cannulate the common bile duct, inabilityto account for anatomical alterations, particularly when during heavilydiseased states. Utilizing the magnetic closure force profile asdescribed herein would allow minimal bleeding and create asemi-permanent slit profile. This slit profile would help to resist“sump syndrome” and help to create a drainage point which would remaineffectively infection free.

Certain exemplary embodiments include a capture device (referred tobelow as a “cap”) for the distal end of an endoscope or other deliverydevice 14 (e.g., laparoscope, catheter, etc.) that is configured formagnetically manipulating certain types of target devices within ahollow body (lumen) of a patient. Exemplary cap embodiments aredescribed herein for use with compression anastomosis devices of thetypes described herein (e.g., self-assembling magnetic compressionanastomosis devices 16), although it should be noted that capsadditionally or alternatively can be configured or used for capturingother types of devices such as, for example and without limitation,annular devices, disk or spherical devices, linear or curvilineardevices, solid devices, hollow devices, signal devices, multipledevices, etc. Thus, references to a cap for use with compressionanastomosis devices should be understood to include a cap for use withany such target devices.

Generally speaking, the target devices are magnetic (and sometimesreferred to herein simply as a “magnet”), in which case the cap caninclude magnetic or magnetizable (e.g., metallic or electromagnetic)elements 85 that can magnetically capture the target device, eitherattached to or monolithically formed with the cap. Alternatively, thetarget devices may be non-magnetic but capable of being captured by amagnet, in which case the cap may include magnetic or electromagneticelements 85 that can magnetically capture the target device.

In certain exemplary embodiments, the cap includes anarticulating/folding capture element that allows the cap and anycaptured device to be presented at an angle, e.g., to enable easierinsertion and/or translation through a lumen or body cavity and alsoallows a user to manipulate and align compression anastomosis devices 16and change the presentation angle for transluminal mating, although itshould be noted that many of the capture and release aspects describedherein can be used with non-articulating caps. The cap may include asubstantially clear material to permit viewing through the cap. The capmay be configured to utilize magnetic field sensing to capture, control,mate, and release compression anastomosis devices 16. In preferredembodiments, the device's sensing and holding forces are optimized toonly release the compression anastomosis devices 16 when properly matedand to allow for improperly mated devices to be decoupled, realigned,and properly mated.

FIG. 46 is a schematic diagram showing an exemplary cap with the abilityto capture a compression anastomosis device and present it at an anglesuch as to allow for easier luminal translation, in accordance with oneexemplary embodiment. Here, the cap is depicted as a separate componentthat can be mounted to the distal end of an endoscope or other deliverydevice 14 (e.g., including a circumferential outer skirt for engaging ashaft or tube member such as an endoscope and preferably having acircumferential resilient material or other attachment mechanism forbetter clamping to the delivery device), although it should be notedthat the cap alternatively can be integral to the distal end of anendoscope or other delivery device.

In this exemplary embodiment, the cap includes a cap body 83 having anangled distal end and an articulating cap element 84 (referred to hereinas a “facia”) coupled at the distal end of the cap body 83 and movablebetween at least a first or closed position in which the cap facia 84 isangled substantially with the distal end geometry (e.g., as depicted inFIG. 46 ) and a second or opened position in which the cap facia 84 ispivoted away from the cap body 83 (e.g., as depicted in FIGS. 47 and 48). The cap facia 84 may be coupled to the cap body 83 using anappropriate pivot mechanism 86 (e.g., one or more pins 87 as highlightedin FIG. 47 , or a hinge, a ball-and-socket joint, etc.). The device mayinclude a biasing mechanism 90 such as to bias the cap facia toward theclosed position (e.g., one or more springs 90 as depicted in FIG. 47 ).In the examples of FIGS. 46-48 , the cap facia 84 is configured to movebetween a closed position of approximately 45 degrees to an openposition of approximately 90 degrees relative to the nominal plane ofthe endoscope or other delivery device 14, although alternativeembodiments can be configured with other geometries (e.g., closing toless than 45 degrees and/or opening to greater than 90 degrees).

The cap facia 84 includes a mechanism for capturing a magneticanastomosis device 16. In this example, the cap facia 84 includes one ormore magnets 85 to capture a magnetic anastomosis device 16, althoughother mechanisms can be used in various alternative embodiments (e.g.,mechanical or electromechanical devices that can grasp or otherwiseretain the anastomosis device 16, an adhesive component that can securethe anastomosis device, etc.). It should be noted that magnets 85 caninclude electromagnets that can be configured to allow for providingfixed or variable magnetic field strengths such as, for example, toproduce different magnetic field strengths for capturing, holding, andreleasing compression anastomosis devices over a range of conditions(e.g., different device sizes, different device magnetic configurations,different tissue types/thicknesses, etc.).

In some embodiments, the cap body 83 may include channels 99 in order topass fluid and/or air through the cap body 83. This may be done in orderto maintain visibility through the cap body and/or maintain the suctionof the endoscope 14.

In the example of FIG. 47 , pressure applied at an extension at thebottom of the cap facia 84 causes the cap facia 84 to move from theclosed position toward the open position relative to the cap body 83.This pressure can be caused, for example, from pushing the deviceagainst tissue or against another magnetic anastomosis device 16.

Additionally or alternatively, a force produced by interaction with anopposing magnetic anastomosis device 16 may cause the cap facia 84 tomove from the closed position toward the open position relative to thecap body 83, such as, for example, when a first magnetic anastomosisdevice being delivered interacts with a previously delivered magneticanastomosis device as the distance between the two magnetic anastomosisdevices decreases.

Additionally or alternatively, the cap may include an actuationmechanism for controlling the position of the cap facia 84 relative tothe cap body 83. FIG. 48 depicts one type of actuation mechanismincluding control guides 88 that can be operated to control the positionof the cap facia 84, although other mechanisms can be used in variousalternative embodiments (e.g., mechanical, electromechanical, etc.).

In certain exemplary embodiments, the cap additionally or alternativelymay be configured to allow for greater degrees of movement. FIG. 49depicts a universal joint 91 comprising articulating hinges to providethree degrees of freedom, although other mechanisms can be used invarious alternative embodiments (e.g., a hinge, a ball-and-socket joint,etc.). It should be noted that any included actuation mechanismgenerally would allow for control of the cap position and movementthrough any desired range of motion.

As shown, for example, in FIG. 46 , the cap 83 and facia 84 may providean opening 92 to allow material or fluid to through the cap and alsoprevent visual or material obstruction when coupling the anastomosisdevice 16 or otherwise creating the anastomosis.

As discussed above, in preferred embodiments, the device's sensing andholding forces are optimized to only release or allow the release of thecompression anastomosis device when properly mated and to allow forimproperly mated devices to be decoupled, realigned, and properly mated.Thus, generally speaking, the cap is configured to have a predeterminedholding force with regard to a particular compression anastomosis device16, and this predetermined holding force can be configured or otherwiseselected such that the compression anastomosis device 16 can be releasedonly when the coupling force through coupling with another compressionanastomosis device 16 is greater than the holding force. Once thecoupling force is greater than the holding force, the compressionanastomosis device 16 could release from the cap automatically or whenthe delivery device 100 is retracted. The holding force can becontrolled in any of various ways, such as, for example and withoutlimitation, the number of magnets or metallic elements 85 on the cap,the size of magnets or metallic elements 85 on the cap, the strength ofmagnets 85 on the cap, the cap/facia 84 material, the manner in whichone or more magnets or metallic elements 85 are secured by the cap/facia(e.g., attached to the cap, embedded in the cap, etc.), to name but afew. The coupling force in turn can be affected by a number of factorsincluding, without limitation, the configuration of the compressionanastomosis devices 16, tissue type/thickness, blood flow or perfusion,etc. Exemplary embodiments can include different caps with differentconfigurations and sizes (e.g., outer diameters) for use with differenttarget devices, tissue type/thicknesses, etc. In these exemplaryembodiments, the magnetic sensing can be considered passive, as it isbased on the configurations and interactions of the cap and compressionanastomosis devices 16.

Additionally or alternatively, the holding force can be accomplishedusing mechanical or electromechanical components (e.g., graspingelements), adhesive, or other components that hold the compressionanastomosis device 16 unless and until the coupling force is greaterthan a predetermined level e.g., overcoming the holding force orotherwise releasing the holding mechanism. For example, the couplingforce could be actively sensed (e.g., using a magnetic sensor, forcesensor, etc.) and used to release the compression anastomosis device 16(e.g., mechanically or electromechanically such as by opening graspingelements or physically separating the compression anastomosis device 16from the cap). Thus, for example, the compression anastomosis device 16could be release when the magnetic field is detected at greater than Xgauss. In certain exemplary embodiments, the cap additionally oralternatively can include one or more sensors (e.g., thin film sensors)to measure and detect different parameters such as force, pressure,and/or magnetic induction, e.g., as it pertains to coupling betweencompression anastomosis devices. This can be used for providing feedbackto the user in real time. The feedback may also include light, sound,screen, and/or other indicators.

FIG. 50 is a schematic diagram showing a cap with one or more sensorsthat are in communication with an electronic interface 93 through whichfeedback can be provided to the user, in accordance with one exemplaryembodiment. It should be noted that a similar mechanism can be used withelectronic actuators on the cap to electronically control, for example,the position and movements of the cap and/or the amount of capture force(e.g., for capturing and releasing a magnetic anastomosis device). Thus,for example, certain embodiments can include one or more electronicsensors and/or one or more electronic actuators. It should be noted thatsuch sensors and/or actuators can be used in certain exemplaryembodiments in addition to, or in lieu of, an angled and/or movable cap.In one embodiment the cap may have a thin film sensor on the cap facia84 to measure and/or detect one or more parameters such as force,pressure, and/or magnetic induction. This can be used for feedback forthe user in real time. For example, a thin film strain gauge 94 maytransfer data on one or more parameters to the electronic interface 93as feedback to the user. The feedback may also include light, sound,screen, and/or other indicators.

Without limitation, sensor systems of the types described above can beused to monitor the position of the captured anastomosis device relativeto a corresponding anastomosis device such as for notifying the userand/or preventing releasing of the captured anastomosis device 16 b whenthe anastomosis device 16 b is not adequately positioned for mating witha corresponding anastomosis device 16 a. For example, in certainexemplary embodiments, the sensor system can be configured to detectconditions of the types depicted in FIG. 51 , e.g., (A) Magnets 16 a, 16b are in a “Venn Diagram” arrangement; (B) Magnets 16 a, 16 b are in a“Figure Eight” arrangement; or (C) Magnets 16 a, 16 b are separated bymore than a predetermined distance (e.g., more than around 4 mm) suchas, for example, due to tissue thickness or obstruction. Sensing can beaccomplished, for example, by force, pressure, and/or magnetic inductionmeasurements.

FIG. 52 shows an alternative cap configuration in which the cap isconfigured (e.g., spring-loaded 90) to open when extended from the shaftmember 89 opening. This exemplary embodiment includes two opening orspring members 90, although it should be noted that alternativeembodiments can include more than two opening members (e.g., three,four, etc.). The exemplary cap of FIG. 52 includes one or more arms 300(while two arms are shown, one arm or more is possible) for capturing ananastomosis device. The cap has a working channel 92 throughout itslength to allow magnetic device 16 and other material to flow throughthe cap. In one embodiment, the cap is stored at a 180 degree anglerelative to the scope 14. Upon exiting the shaft member 83, the capopens perpendicular to the scope 14 in order to capture an anastomosisdevice 16. The arms can be opened by spring loaded members 90 or otheractuating members that allow the cap to open to an angle of 90 degrees.The cap shown in FIG. 52 can include any of the elements describedabove, e.g., magnets 85 or other mechanism for capturing an anastomosisdevice, selective sensing and release of the anastomosis device based onthe coupling force, a pivoting mechanism to allow the capturedanastomosis device to be presented at an angle after capture, auniversal joint or other mechanism providing additional degrees offreedom, actuators for controlling the position and movement of the cap,and/or electronic sensors and/or actuators.

FIGS. 54A-54J show an exemplary flexible and manipulable delivery devicehaving an angled cap at the distal end for selectively delivering,capturing, and releasing a magnetic compression anastomosis device, inaccordance with one exemplary embodiment.

FIG. 54A shows the device prior to deployment of the compressionanastomosis device. In this example, the cap facia 84 includes twomagnets 85 for capturing a deployed compression anastomosis device orother device. In this example, the cap facia 84 is stored at a 45 degreeangle to the delivery device such as an endoscope 14.

FIG. 54B shows the device after deployment and self-assembly of thecompression anastomosis device 16. The magnetic anastomosis device 16 isdeployed from the delivery device 14 through the hole in the cap facia84. The magnet self-assembles into a polygonal shape, in this example anoctagon, and is attached to the scope by sutures 60 or another controlwire. At this point, the magnet 16 is not yet aligned or engaged withthe cap facia 84.

FIG. 54C shows the compression anastomosis device 16 captured by themagnets on the angled cap. The magnetic anastomosis device 16 isattracted to the cap facia 84 by attractive magnetic forces from themagnetic devices 85 on the cap facia 84. The magnets 85 on the cap facia84 attract the magnetic anastomosis device 16 and mate it to the capfacia 84 for manipulation and placement. The anastomosis device 16 mayalso be brought to the cap facia 84 by pulling back on the sutures 60attaching the magnetic device 16 to the scope 14.

FIGS. 54D-54H show a sequence of movements of the flexible deliverydevice as induced by an operator at the proximal end of the deliverydevice demonstrating both vertical, horizontal, and rotationaldisplacements of the distal end with captured compression anastomosisdevice.

FIG. 54D shows the magnetic anastomosis device 16 coupled to the capfacia 84 with the cap facia 84 in the stored position of 45 degrees tothe endoscope 14.

FIG. 54E shows a side-view of the magnetic anastomosis device 16 coupledto the cap facia 84 in the stored position of 45 degrees to theendoscope 14. In some embodiments, the cap facia 84 may be stored atangles other than 45 degrees such as perpendicular to the endoscope 14or to an angle less than 45 degrees.

FIG. 54F shows another side-view of the anastomosis device 16 coupled tothe cap facia 84 in the stored position 45 degrees to the end of theendoscope 14.

FIG. 54G shows a flexible scope 14, such as an endoscope, manipulatingthe cap 83 coupled to an anastomosis device 16. By bending the scope 14,the anastomosis device 16 may be manipulated for placement and alignmentat a target anastomosis site.

FIG. 54H shows a side-view of a flexible scope 14 with a capture device83 comprising a cap facia 84 mated to a magnetic anastomosis device 16.The cap facia 84 is in the stored position 45 degrees relative to theendoscope 14.

FIG. 54I shows a simulation of mating of the captured compressionanastomosis device 16 b with a corresponding compression anastomosisdevice 16 a.

FIG. 54J shows a simulation of the captured compression anastomosisdevice 16 releasing from the delivery device 14 due to proper alignmentof the two compression anastomosis devices producing a coupling forcethat overcomes the holding force produced by the cap 83 on the capturedcompression anastomosis device 16. The surgeon may pull back on thedelivery device 14 to decouple the cap facia 84 with the capturedanastomosis device 16 in order to remove the delivery device 14 and cap83 from the patient, leaving behind the compression anastomosis devices.

FIG. 53 shows a laparoscopic magnet navigation device 95 for controllingmovement of a magnetic device 16 within the GI tract or other cavity, inaccordance with certain exemplary embodiments. The following are someexemplary configurations for such a laparoscopic magnet navigationdevice:

-   -   (a) Ferrous laparoscopic tool— Utilizing a tool with        ferromagnetic mass balanced to allow movement of the magnets        through the GI tract starting in the stomach and pulling through        bowel without creating trauma. This will be achieved by using a        gap controlling tip at the end of the laparoscopic wand.        Maintaining the gap will allow the forces displaced on the        magnet to be great enough to drag and manipulate through        anatomical tortuosity without allowing the magnet and tool to        “pinch” tissue.    -   (b) Static field laparoscopic tool—Like the ferrous tool, this        would also have to be a balanced mass approach to have enough        attractive force to allow manipulation without pinching tissue.        The advantage of using another magnet would be reduced footprint        and mass of the laparoscopic wand.    -   (c) Electromagnetic field laparoscopic tool—Utilizing a variable        field laparoscopic manipulation tool would offer great benefits.        Tracking through challenging anatomical features such as the        pylorus or any other narrowing/sphinctered areas in the GI tract        could prove difficult. Being able to vibrate and jostle the        magnet as it approached these anatomical structures would allow        much greater dexterity in manipulating the magnet as well as        providing a very strong field without the worry of pinching        tissue. Pulsing the electromagnetic wand with different wave        forms and patterns would allow the user to have the magnet at a        distance away from the tip and float through the anatomy.

The distal end of the laparoscopic navigation device 95 may comprise amagnet or ferromagnetic metal, such that when capturing a magneticanastomosis device 16 b, the attractive force between two anastomosisdevices 16 a, 16 b is stronger than the magnetic attraction between thelaparoscopic navigation device 95 and the captured magnet 16 b. Thus,because the attractive forces between the laparoscopic device 95 and thecaptured magnet 16 b is less than the attractive forces between the pairof magnets 16 a, 16 b, the laparoscopic device may be easily removedfrom the patient without disturbing the placement of the pair ofmagnetic anastomosis devices 16 a, 16 b.

It should be noted that magnetic navigation devices of the type shown inFIG. 53 essentially have a single point of contact or focus ofinteraction with the compression anastomosis device 16 or other targetdevice cap and can include any of the elements described above, e.g.,magnets or other mechanism for capturing an anastomosis device,selective sensing and release of the anastomosis device based on thecoupling force, a pivoting mechanism to allow the captured anastomosisdevice to be presented at an angle after capture, a universal joint orother mechanism providing additional degrees of freedom, actuators forcontrolling the position and movement of the device, and/or electronicsensors and/or actuators.

INCORPORATION BY REFERENCE

References and citations to other documents, such as patents, patentapplications, patent publications, journals, books, papers, webcontents, have been made throughout this disclosure. All such documentsare hereby incorporated herein by reference in their entirety for allpurposes.

EQUIVALENTS

The invention may be embodied in other specific forms without departingfrom the spirit or essential characteristics thereof. The foregoingembodiments are therefore to be considered in all respects illustrativerather than limiting on the invention described herein. Scope of theinvention is thus indicated by the appended claims rather than by theforegoing description, and all changes which come within the meaning andrange of equivalency of the claims are therefore intended to be embracedtherein.

POTENTIAL CLAIMS

Various embodiments of the present invention may be characterized by thepotential claims listed in the paragraphs following this paragraph (andbefore the actual claims provided at the end of the application). Thesepotential claims form a part of the written description of theapplication. Accordingly, subject matter of the following potentialclaims may be presented as actual claims in later proceedings involvingthis application or any application claiming priority based on thisapplication. Inclusion of such potential claims should not be construedto mean that the actual claims do not cover the subject matter of thepotential claims. Thus, a decision to not present these potential claimsin later proceedings should not be construed as a donation of thesubject matter to the public. Nor are these potential claims intended tolimit various pursued claims.

Without limitation, potential subject matter that may be claimed(prefaced with the letter “P” so as to avoid confusion with the actualclaims presented below) includes:

-   -   P1. A cap having a circumferential outer skirt for engaging a        shaft or tube member such as endoscope and having a        circumferential resilient material for better clamping.    -   P2. A cap having a substantially clear material to permit        viewing through the CAP.    -   P3. An apparatus with the ability to capture and control a        compression anastomosis device in a proximal lumen, allowing for        presentation at different angles relative to the delivery device        to allow for less invasive intraluminal translation and/or        improved mating position.    -   P4. An apparatus having sensing force optimized to automatically        release properly mated compression anastomosis devices and to        maintain sufficient holding force for improperly mated devices        to be decoupled, realigned, and properly mated.    -   P5. A cap having a feedback capability for the user in real        time.    -   P6. A cap having ability to understand tissue type and/or        thickness and/or blood flow or perfusion.    -   P7. Apparatus, device, and method to control and manipulate        magnets that will use the magnetic field sensing to provide user        with confidence that the magnet has been deployed for a property        anastomosis to be made.    -   P8. A laparoscopic magnetic navigation device.    -   P9. The device of claim P8, wherein the device is a ferrous        laparoscopic device.    -   P10. The device of claim P8, wherein the device is a static        field laparoscopic device.    -   P11. The device of claim P8, wherein the device is an        electromagnetic field laparoscopic device in which the magnetic        field can be varied electromagnetically.    -   P12. A cap for a delivery device such as an endoscope,        laparoscope, catheter, etc., the cap including any feature or        combination of features as described.    -   P13. A delivery device such as an endoscope, laparoscope,        catheter, etc., having a cap including any feature or        combination of features as described.    -   P14. A device such as an endoscope, laparoscope, catheter, etc.,        having a distal end including an articulating element for        selectively capturing, manipulating, and releasing a target        device in accordance with any feature or combination of features        described.    -   P15. A device such as an endoscope, laparoscope, catheter, etc.,        having a distal end including an element for selectively        capturing, manipulating, and releasing a target device in        accordance with any feature or combination of features        described, wherein the element is configured to release the        target device only when a separation force on the target device        is greater than a holding force of the element.    -   P16. A device such as an endoscope, laparoscope, catheter, etc.,        having a distal end including an element for selectively        capturing, manipulating, and releasing a target device in        accordance with any feature or combination of features        described, wherein the element is configured to release the        target device only when a separation force on the target device        is greater than a predetermined separation force.    -   P17. A device such as an endoscope, laparoscope, catheter, etc.,        having a distal end including an element for selectively        capturing, manipulating, and releasing a target device in        accordance with any feature or combination of features        described, wherein the element is configured to release the        target device only when a magnetic field interacting with the        target device is greater than a predetermined level.    -   P18. A device configured to capture and control a rigid magnet        such as for steering the magnet into position for an anastomosis        procedure.    -   P19. A medical device having a distal end, the medical device        comprising:        -   a cap configured for attaching to the distal end of the            medical device, the cap including a magnetizable portion;        -   a first magnet for attaching to the magnetizable portion of            the cap;        -   the cap and the first magnet having a first force            therebetween;        -   a second magnet for attaching to the first magnet and having            a second force therebetween; and        -   the second force being greater than the first force for            separating the first magnet from the cap.    -   P20. The apparatus of claim P19 further comprising:        -   sensing capabilities to detect magnetic force to capture            and/or release a magnetic anastomosis device.    -   P21. The apparatus of claim P19 further comprising:        -   the cap having a substantially clear material to allow            viewing through the cap.    -   P22. The apparatus of claim P19 further comprising:        -   the cap having an inner working channel throughout the            length of the cap to allow material to pass through the cap.    -   P23. The apparatus of claim P19 further comprising:        -   a sensing force optimized to automatically release properly            mated compression anastomosis devices and to maintain            sufficient holding force for improperly mated devices to be            decoupled, realigned, and properly mated.    -   P24. The apparatus of claim P19 further comprising:        -   a feedback capability for a user in real time.    -   P25. The apparatus of claim P19 further comprising:        -   the ability to understand tissue type and/or thickness            and/or blood flow or perfusion.    -   P26. The apparatus of claim P19 further comprising:        -   control guides attached to the cap facia capable of            articulating the cap facia relative to the cap body.    -   P27. The apparatus of claim P19 further comprising:        -   a spring-loaded shaft member in the cap body capable of            releasing the cap facia from a stored position to a deployed            position.    -   P28. The apparatus of claim P19 further comprising:        -   one or more channels within the cap body having a capability            of passing fluid and/or air through the cap body.    -   P29. The apparatus of claim P19 further wherein the cap facia        comprises one or more arms capable of capturing and manipulating        a magnetic device.

1. An apparatus for capturing and manipulating a magnetic compressionanastomosis device, the apparatus comprising: a cap configured to attachto a delivery device, the cap comprising: a cap body having a distal endand a proximal end through which the cap body is coupled to the deliverydevice, the distal end having an angled distal end geometry that isangled back toward the proximal end at an angle less than 90 degreesrelative to a longitudinal axis of the cap body; and an articulating capfacia coupled at the distal end of the cap body and movable between atleast a closed position and a fully-opened position, the articulatingcap facia including at least one capture device configured to capture amagnetic anastomosis device, wherein: in the closed position, the capfacia is angled substantially with the angled distal end geometry, andin the fully-opened position, the cap facia is pivoted away from theangled distal end geometry to an angle of at least around 90 degreesrelative to the longitudinal axis of the cap body.
 2. The apparatus ofclaim 1, wherein the angled distal end geometry is angled back towardthe proximal end at an angle of around 45 degrees relative to thelongitudinal axis of the cap body.
 3. The apparatus of claim 1, whereinthe at least one capture device includes one or more magnets.
 4. Theapparatus of claim 1, wherein the at least one capture device includesat least one electromagnet configured to provide a fixed magnetic fieldstrength.
 5. The apparatus of claim 1, wherein the at least one capturedevice includes at least one electromagnet configured to providedifferent magnetic field strengths for capturing, holding, and releasingcompression anastomosis devices over a range of conditions.
 6. Theapparatus of claim 1, wherein the at least one capture device includesat least one device capable of grasping or retaining the magneticanastomosis device.
 7. The apparatus of claim 1, wherein the at leastone capture device includes at least one adhesive device.
 8. Theapparatus of claim 1, wherein the cap facia is coupled to the cap bodyusing at least one pivot.
 9. The apparatus of claim 8, wherein the atleast one pivot includes one or more pins.
 10. The apparatus of claim 8,wherein the at least one pivot includes at least one hinge.
 11. Theapparatus of claim 8, wherein the at least one pivot includes at leastone ball-and-socket joint.
 12. The apparatus of claim 1, furthercomprising: at least one biasing device configured to bias the cap faciatoward the closed position.
 13. The apparatus of claim 12, wherein theat least one biasing device includes one or more springs.
 14. Theapparatus of claim 1, wherein the closed position is less than or equalto approximately 45 degrees relative to the longitudinal axis of the capbody.
 15. The apparatus of claim 1, wherein the fully-opened position isgreater than or equal to approximately 90 degrees relative to thelongitudinal axis of the cap body.
 16. The apparatus of claim 1, whereinthe cap facia includes an extension that causes the cap facia to pivotfrom the closed position toward the fully-opened position when pressureis applied to the extension.
 17. The apparatus of claim 1, wherein thecap facia is configured to move from the closed position toward thefully-opened position when a sufficient magnetic interaction forceexists between a magnetic anastomosis device captured by the cap faciaand an opposing magnetic anastomosis device.
 18. The apparatus of claim1, wherein the cap further comprises: at least one actuator configuredto remotely control position of the cap facia relative to the cap body.19. The apparatus of claim 18, wherein the at least one actuatorcomprises a spring-loaded mechanism capable of releasing the cap faciafrom the closed position to the fully-opened position.
 20. The apparatusof claim 1, wherein the distal end of the cap body is movable relativeto the proximal end of the cap body.
 21. The apparatus of claim 20,wherein the cap body includes a universal joint, hinge, orball-and-socket joint between the distal end and the proximal end toallow movement of distal end relative to the proximal end.
 22. Theapparatus of claim 20, wherein the cap further comprises: at least oneactuator configured to remotely control position of the distal endrelative to the proximal end.
 23. The apparatus of claim 20, wherein thecap further comprises: at least one sensor to sense position of thedistal end relative to the proximal end and provide position feedback toa user.
 24. The apparatus of claim 1, wherein the cap body is formed ofa substantially clear material to permit viewing through the cap. 25.The apparatus of claim 1, wherein the cap facia has a diameter greaterthan a diameter of the cap body.
 26. The apparatus of claim 1, whereinthe cap body includes at least one channel extending through the capbody.
 27. The apparatus of claim 26, wherein at least one of: the atleast one channel is adapted for passing of fluid and/or air through thecap body; the at least one channel is adapted for passing an instrumentthrough the cap body; the at least one channel is adapted for allowingvisibility through the cap body; or the at least one channel is adaptedfor delivering suction through the cap body.
 28. The apparatus of claim1, wherein the at least one capture device is configured toautomatically release the captured magnetic anastomosis device when thecaptured magnetic anastomosis device is properly mated with an opposingmagnetic anastomosis device and to retain the captured magneticanastomosis device when the captured magnetic anastomosis device isinsufficiently mated with an opposing magnetic anastomosis device. 29.The apparatus of claim 1, further comprising the delivery deviceattached to the cap.
 30. The apparatus of claim 29, wherein the deliverydevice is one of: an endoscope; a laparoscope, or a catheter.